A fully automated paper-based smartphone-assisted microfluidic chemiluminescence sample to result immunoassay platform

IF 5.7 2区化学 Q1 CHEMISTRY, ANALYTICAL

Analytica Chimica Acta Pub Date : 2025-04-10 DOI:10.1016/j.aca.2025.344013

Jihong Sun , Sixuan Duan , Weiqin Xu , Wenjun He , Tong Li , Sanli Liu , Kai Hoettges , Junhui Zhu , Mark Leach , Pengfei Song

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引用次数: 0

Abstract

Background

In recent years, adapting immunoassay technologies for point-of-care testing (POCT) to enable low-cost, on-site diagnostics has gained great attention. Among the various approaches to achieving this goal, microfluidic paper-based analytical devices (μPADs) have emerged as a promising platform. These devices are particularly appealing due to their low cost, simple procedures, and minimal sample consumption. Among the detection methods used in μPADs, chemiluminescence (CL) has attracted widespread attention for its high sensitivity. However, existing CL immunoassays often require expensive detection equipment and extensive manual operation, which limits their use in resource-poor areas or where trained personnel are lacking.

Results

In this study, we developed a newly designed μPAD for CL immunoassays, leveraging smartphone-based image capture, valve-regulated reaction process, and app-driven result analysis to enable fully automated detection. Each element of the device was highly integrated and designed for programmable operation, enhancing reliability and stability. An app was developed to manage the entire process, maximizing the convenience of smartphones. The device's effectiveness was calibrated using rabbit IgG as a model, achieving a limit of detection (LOD) of 62.4 pg/mL, which represents an improvement compared to the colorimetric ELISA method with a LOD of 3 ng/mL (20pM). We then applied the device to detect tau protein, a biomarker associated with Alzheimer's disease and achieved a detection limit of 26.1 pg/mL, which is lower than the clinical cut-off value.

Significance

Our device achieves complete automation and integrates the versatility of μPADs with the precision of CL immunoassays, offering an effective and accessible solution for POCT. By incorporating a user-friendly smartphone interface, it simplifies operation while maintain detection sensitivity, providing a practical and valuable improvement in the development of POCT technologies.

Abstract Image

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基于纸张的全自动智能手机辅助微流控化学发光样品-结果免疫分析平台

近年来，将免疫分析技术应用于护理点检测（POCT）以实现低成本的现场诊断得到了极大的关注。在实现这一目标的各种方法中，微流控纸基分析装置（μPADs）已经成为一个有前途的平台。这些设备由于其低成本、简单的程序和最小的样品消耗而特别吸引人。在μPADs的检测方法中，化学发光法（CL）因其高灵敏度而受到广泛关注。然而，现有的CL免疫测定法往往需要昂贵的检测设备和大量的人工操作，这限制了它们在资源贫乏地区或缺乏训练有素人员的地区的使用。在本研究中，我们开发了一种新设计的用于CL免疫测定的μPAD，利用基于智能手机的图像捕获、阀控反应过程和应用程序驱动的结果分析来实现全自动检测。设备的每个元件都高度集成，设计用于可编程操作，增强了可靠性和稳定性。开发了一个应用程序来管理整个过程，最大限度地利用智能手机的便利性。以兔IgG为模型对该装置的有效性进行了标定，检测限（LOD）为62.4 pg/mL，与比色ELISA法的LOD为3 ng/mL （20pM）相比有了提高。随后，我们将该装置用于检测与阿尔茨海默病相关的生物标志物tau蛋白，检测限为26.1 pg/mL，低于临床临界值。我们的设备实现了完全的自动化，并将μPADs的多功能性与CL免疫测定的精确性相结合，为POCT提供了一种有效且易于获取的解决方案。通过结合用户友好的智能手机界面，它简化了操作，同时保持了检测灵敏度，为POCT技术的发展提供了实用和有价值的改进。

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来源期刊

Analytica Chimica Acta 化学-分析化学

CiteScore

10.40

自引率

6.50%

发文量

1081

审稿时长

38 days

期刊介绍： Analytica Chimica Acta has an open access mirror journal Analytica Chimica Acta: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. Analytica Chimica Acta provides a forum for the rapid publication of original research, and critical, comprehensive reviews dealing with all aspects of fundamental and applied modern analytical chemistry. The journal welcomes the submission of research papers which report studies concerning the development of new and significant analytical methodologies. In determining the suitability of submitted articles for publication, particular scrutiny will be placed on the degree of novelty and impact of the research and the extent to which it adds to the existing body of knowledge in analytical chemistry.